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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 202736
Company: ARBOR PHARMS LLC

Summary Review

Products on NDA 202736

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SKLICE	IVERMECTIN	0.5%	LOTION;TOPICAL	Over-the-counter	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 202736

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/07/2012	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202736Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202736s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202736_sklice_toc.html https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202736Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/28/2021	SUPPL-9		Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202736Orig1s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/202736Orig1s009ltr.pdf
10/27/2020	SUPPL-6	Efficacy-Rx To OTC Switch	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202736Orig1s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/202736Orig1s006ltr.pdf
06/16/2017	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202736s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202736Orig1s003ltr.pdf

Labels for NDA 202736

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/28/2021	SUPPL-9	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202736Orig1s009lbl.pdf
10/27/2020	SUPPL-6	Efficacy-Rx To OTC Switch	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202736Orig1s006lbl.pdf
06/16/2017	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202736s003lbl.pdf
02/07/2012	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202736Orig1s000lbl.pdf

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

SKLICE

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

LOTION;TOPICAL; 0.5%

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
IVERMECTIN	IVERMECTIN	0.5%	LOTION;TOPICAL	Over-the-counter	No	210720	TARO
SKLICE	IVERMECTIN	0.5%	LOTION;TOPICAL	Over-the-counter	Yes	202736	ARBOR PHARMS LLC

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